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MALIC ACID

Clinical trials investigating MALIC ACID are studying critically ill patients with metabolic acidosis and acute kidney injury. These trials aim to evaluate clinical effectiveness and kidney outcomes, especially major adverse kidney events at 90 days. The main study is a Phase 3 interventional trial in hospitalized patients.

Table of contents

Trial overview

The available trial data describe one interventional study of MALIC ACID in critically ill patients with metabolic acidosis and acute kidney injury.[1] The study title says it is evaluating the clinical effectiveness of sodium bicarbonate for these patients.[1]

Who is being studied

The target population is patients who are seriously ill and have both metabolic acidosis and acute kidney injury.[1] The data do not give more detailed entry rules, such as age limits or specific hospital settings.[1]

Study design and phase

This is an interventional trial, which means researchers are testing a treatment and observing patient outcomes.[1] It is a Phase 3 study with planned enrollment of 660 people.[1]

The interventions listed include sodium bicarbonate and several comparison infusion solutions, such as Jonosteril Infusionslösung, Elektrolyt-Infusionslösung 153, Sterofundin ISO Infusionslösung, and Ringer-Infusionslösung B. Braun.[1] The trial data do not explain the full comparison plan, but they show that the study is testing treatment options given by intravenous infusion.[1]

What is being measured

The main outcome is Major adverse kidney events (MAKE90).[1] This is a combined endpoint, meaning several important results are grouped into one measure.[1]

MAKE90 includes death, any kidney replacement therapy within 90 days after randomization, or persistent renal dysfunction at day 90, defined as creatinine at least 200% of baseline.[1] In simple terms, the study is checking whether treatment helps protect the kidneys and improve survival over the first 90 days.[1]

Trial status and size

The trial status is listed as Authorised.[1] The planned enrollment is 660 participants, which suggests a fairly large study for a Phase 3 trial.[1]

Because only one trial record is provided, the current evidence here is limited to this single study description.[1]

Trial ID Phase Condition studied Status Enrollment
2025-523914-10-00 Phase 3 Metabolic acidosis, critical illness, acute kidney injury Authorised 660

FAQ

  • What are the MALIC ACID trials studying? The trial data provided focus on clinical effectiveness in critically ill patients with metabolic acidosis and acute kidney injury. The main outcome is whether treatment changes major adverse kidney events at 90 days.
  • Who can take part in these trials? The studied group is critically ill patients who have metabolic acidosis and acute kidney injury. The trial data do not give more detailed eligibility rules.
  • What phase is the MALIC ACID trial? The trial is a Phase 3 study. Phase 3 trials usually test whether a treatment works in a larger group of patients and measure important clinical outcomes.
  • What condition is being studied? The trial is focused on metabolic acidosis and acute kidney injury in critically ill patients. These are serious conditions seen in hospital or intensive care settings.
  • What outcome is being measured? The main outcome is major adverse kidney events, called MAKE90. This includes death, need for kidney replacement therapy, or lasting kidney dysfunction by day 90.

Ongoing Clinical Trials on MALIC ACID

  • Effect of sodium hydrogen carbonate on kidney health in critically ill patients with metabolic acidosis and acute kidney injury

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Critical illness: A serious medical state where a patient needs close hospital or intensive care monitoring.
  • Metabolic acidosis: A condition where the blood becomes too acidic because the body has an imbalance in acids and bases.
  • Acute kidney injury: A sudden decrease in kidney function that happens over a short time.
  • Interventional study: A clinical trial where researchers give a treatment and compare results.
  • Phase 3: A later stage trial that studies whether a treatment works well and how it affects important patient outcomes.
  • Enrollment: The number of people planned to join a study.
  • Primary outcome: The main result researchers want to measure in a trial.
  • Major adverse kidney events (MAKE90): A combined outcome that includes death, need for kidney replacement therapy, or ongoing kidney problems at 90 days.
  • Kidney replacement therapy (KRT): Treatment that helps the kidneys do their job when they are not working properly, such as dialysis.
  • Persistent renal dysfunction: Ongoing kidney problems that are still present after a period of time.

References

  1. https://clinicaltrials.gov/study/2025-523914-10-00